The Orthocon OrthoStat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.

Device Description

Orthocon OrthoStat™ Hemostatic Bone Putty is a sterile, soft, moldable, biocompatible, absorbable material of putty-like consistency intended for use in the management of bleeding from the cut surface of bone. The material is a mixture of calcium stearate (a wax-like tamponade), Vitamin E Acetate (for handling properties) and alkylene oxide copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature. When applied manually to surgically incised or traumatically broken bone, OrthoStat Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

AI/ML Overview

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way typically expected for a diagnostic AI/ML device.

The document is a 510(k) summary for a medical device called "OrthoStat™ Hemostatic Bone Putty." It focuses on demonstrating substantial equivalence to predicate devices for its intended use, rather than proving diagnostic performance against specific metrics with a test set, ground truth, or expert review.

Here's a breakdown of why the requested information cannot be extracted from this document:

Device Type: OrthoStat™ Hemostatic Bone Putty is a hemostatic agent (a physical barrier to stop bleeding), not an AI/ML diagnostic tool or a device that interprets data for diagnosis. Therefore, the concepts of "acceptance criteria for device performance" in terms of accuracy, sensitivity, specificity, etc., or "expert ground truth" as applied to diagnostic image interpretation, do not apply.
Study Focus: The "studies" mentioned are typically engineering tests, biocompatibility assessments, and functionality/efficacy testing to show the device performs its intended mechanical function (stopping bleeding) and is safe. These are not comparative effectiveness studies with human readers or standalone algorithm performance studies.
"Acceptance Criteria" in this Context: For a device like bone putty, "acceptance criteria" likely refer to successful outcomes in non-clinical tests (e.g., in vitro or animal models) showing it effectively stops bleeding, is absorbed within a specified timeframe, and is biocompatible. These are not explicitly detailed here with numerical targets as would be for a diagnostic tool.

Therefore, I cannot provide the requested table and information because the document describes a different type of medical device and regulatory submission where those specific performance metrics, study designs, and ground truth methodologies are not applicable or detailed.

The document states:

"The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results, absorption testing and biocompatibility testing."
"The data presented demonstrate that the device is biocompatible and is suitable for its indicated use."

This indicates that these tests were performed to support the "suitability for indicated use" and "biocompatibility," which are the operational criteria for this type of device. However, the specifics of these results and their acceptance criteria are not presented in the provided text.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)

General Company Information

Name:	Orthocon, LLC
Contact:	Howard Schrayer
	Regulatory Affairs Consultant

Address: 167 Stone Hill Road Colts Neck, NJ 07722
Telephone: (732) 683 - 9304 Fax: (732) 683 - 9476
July 21, 2005 Date Prepared

General Device Information

Product Name:	OrthoStat™ Hemostatic Bone Putty
Classification:	"Bone Wax", Product code: MTJUnclassified

Predicate Devices

CP Medical, Inc. - CP Medical Bone Wax 510(k) Number K024372

Ethicon, Inc. Bone Wax - Pre-enactment

United States Surgical Corporation Bone Wax 510(k) Number K971680 (Absorbable)

Ceremed AOC Bone Wax 510(k) Number K041363 (Absorbable)

Description

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K043260 page 2/2

Page 98 of 98

copolymer (a dispersing agent). The material is virtually odorless, off-white in color and can be spread easily with minimal adhesion to surgical gloves. The bone putty requires no kneading prior to application and does not soften appreciably at body temperature.

When applied manually to surgically incised or traumatically broken bone, OrthoStat Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). The bone putty will be dispersed and absorbed within a period of 60 days.

Intended Use (Indications)

Orthocon OrthoStat™ Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The moterial may be used during surgical procedures and in treating traumatic injuries.

Substantial Equivalence

This submission supports the position that the Orthocon OrthoStat™ Hemostatic Bone Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:

CP Medical Bone Wax - [501(k) Number K032930] Lukens Bone Wax - [510(k) K791495] Aesculap Bone Wax - [510(k) K000021] Ethicon Bone Wax - Pre-enactment United States Surgical Corporation Bone Wax – [510(k) Number K971680] (Absorbable) Ceremed AOC Bone Wax - [510(k) Number K041363] (Absorbable)

The 510(k) Notice contains summaries of physical test results, functionality (efficacy testing) results, absorption testing and biocompatibility testing.

The data presented demonstrate that the device is biocompatible and is suitable for its indicated use. The single-patient-use OrthoStat™ Hemostatic Bone Putty is provided sterile.

Conclusions

Orthocon, LLC believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Orthgoon OrthoStat™ Hemostatic Bone Putty. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The text is black against a white background.

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Howard L. Schrayer Regulatory Affairs Consultant Orthocon, LLC 167 Stone Hill Road Colts Neck, New Jersey 07722

Re: K043260

Trade/Device Name: Orthocon, OrthoStat™ Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: July 22, 2005 Received: July 25, 2005

Dear Mr. Schrayer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Howard L. Schrayer

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in Joan Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Soubare Buechd

M. N. Mcllwraith

Mark N. Melkerso Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K043260

Device Name: Orthocon, OrthoStat™ Hemostatic Bone Putty

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

bare Bnechuf for Mettorson
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K043260

Regulation Number and Section

N/A